Regulatory
IP. The information must be at the right level, so patients can see what is happening and what trials they can participate in. But sponsors and regulators have different ideas about the balance point between privacy and transparency.”
“The transparency change is a fantastic move,” says Olsen. “It is one of the great things about CTR and CTIS. Before, we could not see the protocols of another trial. Now, everything is how it should be and there are no secrets as academic sponsors. Pharma companies do have secrets but they are not necessarily revealed in the protocol. It is about balance.”
Signs of success
Europe’s clinical trials declined sharply over the past decade, but the new streamlined regulations aim to reverse this trend.
“Many things have been done to improve CTIS and we are working on it on a daily basis,” explains Petersen. “It is functional, but only a minimal viable product was initially launched. Some things are not working yet, but a lot of work is being put in. The environment is functional and there is an organic process of development to end up with what people actually need.” Academic trials, such as those led by Olsen, helped to unearth all the huge number of bugs, many of which have been worked out. Olsen freely admits that the system is now much more mature, though error reports still abound. On the regulatory side, too, small improvements are continuously being made to clarify the rules and get rid of some workarounds.
“The amount of workarounds was incredible... We could write a massive book about the errors in CTIS, but it is getting better and they are learning.”
Lene Grejs Petersen 6.3% GlobalData 10
The percentage decline in clinical trials in Europe in the 10 years to 2020.
The latest regulatory changes concern transparency, which is a hot topic for industry sponsors concerned about revealing their intellectual property. The key changes will mean fewer documents will be made publicly available, so less redaction will be required. Only protocol, synopsis, patient-facing documents, the summary of product characteristics, recruitment arrangements, and the summary of results, where available, will be needed. Furthermore, the deferral option will be removed from CTIS.
“These rules will be helpful,” believes Petersen.
“Today, almost everything could potentially be published, even the questions to sponsors and their
There are some early signs that clinical trial activity is returning to Europe, as sponsors are finding it easier to make use of the new system – and come to appreciate that initial obstacles are being removed.
“Running multinational trials in the EU is now
simpler,” observes Olsen. “There is one system and all feedback is centralised, so we can now run trials in 20 EU countries at the same time, which would have been very difficult before. But the caveat is that it is less flexible.”
The lack of regulatory harmonisation between member states is a complicating factor, but different interpretations will not necessarily cause CTR and CTIS to fail. Regulators want sponsors to submit in as many member states as possible to benefit as many patients as possible, and the EC’s templates for Part II – national and patient- level documentation – might be widely adopted. Even without full regulatory harmonisation, a more positive picture is emerging from the numbers, though definitive figures are not yet available. “The number of applications is rising again,” notes Petersen. “There were obstacles but it is becoming easier for them to make the transition. The system is actually viable and people are using it. In Denmark, the first three months were very busy. Some member states are up, others are down, and last year you could use the old system or the new system, so the figures don’t yet give a clear picture.” “Running multinational trials in the EU is now
simpler, particularly for pharma companies, as you have one process,” observes Olsen. “There is one system and all feedback is centralised, so we can now run trials in 20 EU countries at the same time, which would have been very difficult before. But the caveat is that it is less flexible.” Clearly, there are issues to resolve at technical and regulatory levels, but there are positive signs. However, one other important caveat remains – running trials in Europe is still not particularly cheap, and that is unlikely to change any time soon. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
bearsky23/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37
